Introduction

Uses for QVAR

Asthma

Used for the long-term prevention of bronchospasm in patients with asthma.12821242526103112113116144149152

Should not be used in the treatment of nonasthmatic bronchitis.128112113144

Chronic Obstructive Pulmonary Disease

Efficacy in patients with chronic obstructive pulmonary disease (e.g., bronchitis)† who are stabilized with oral corticosteroids333437117 or whose disease is corticosteroid responsive117118 remains to be fully evaluated.

Inflammatory Conditions of the GI Tract

Has been used as an oral solution35 or rectal suspension36 (these dosage forms not commercially available in the US) in the management of inflammatory diseases of the GI tract† (e.g., inflammatory bowel disease†, eosinophilic gastroenteritis†).3536 However, the role of beclomethasone dipropionate in the management of inflammatory conditions of the GI tract remains to be established.3536

QVAR Dosage and Administration

General

Adjust dosage carefully according to individual requirements and response.126183112113144149

After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response.149150 Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth.149150 (See Pediatric Use under Cautions.)

When switching from systemic corticosteroids to orally inhaled beclomethasone dipropionate, asthma should be reasonably stable before initiating treatment with the oral inhalation.12112113144149

Initially, administer the aerosol concurrently with the maintenance dosage of the systemic corticosteroid.12112113144149 After about 1 week, gradually withdraw the systemic corticosteroid.12112113144149

Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.12112113144149 (See Withdrawal of Systemic Corticosteroid Therapy under Warnings.)

If exacerbations of asthma occur after transfer to oral inhalation therapy, administer short courses of systemic corticosteroids, then taper dosage as symptoms subside.12112113144149

Administration

Oral Inhalation

Administer by oral inhalation using an oral aerosol inhaler.149

Test-spray inhalation aerosol (2 times) before first use or whenever the aerosol not used for prolonged periods (>10 days).149b

Oral inhalation aerosol is formulated as a solution, which does not require shaking.149

Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed firmly around it; keep the tongue below the mouthpiece.b Inhale slowly and deeply through the mouth while actuating the inhaler.b Hold the breath for as long as possible (about 5–10 seconds), withdraw the mouthpiece, and exhale gently.b If additional inhalations are required, repeat the procedure.b

Rinse the mouth thoroughly with water to remove drug deposited in the oropharyngeal area.3348495259149b

Clean the mouthpiece weeklyb using a clean, dry tissue or cloth.b Do not wash or place any part of the inhaler canister in water.b

Dosage

Available as beclomethasone dipropionate; dosage expressed in terms of the salt.b149

Pediatric Patients

Asthma

Oral Inhalation

Children 5–11 years of age receiving bronchodilators alone or inhaled corticosteroids previously: Initially, 40 mcg twice daily.149 If required, dosage may be increased to a maximum 80 mcg twice daily.149

Children ≥12 years of age receiving bronchodilators alone previously: Initially, 40–80 mcg twice daily.149 If required, dosage may be increased to a maximum 320 mcg twice daily.149

Children ≥12 years of age receiving inhaled corticosteroids previously: Initially, 40–160 mcg twice daily. If required, dosage may be increased to a maximum 320 mcg twice daily.

Contraindications

Known hypersensitivity to the drug or any ingredient in the formulation.12112113144149

Warnings/Precautions

Warnings

Withdrawal Of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression);12112113144149 acute adrenal insufficiency;12112113144 life-threatening exacerbation of asthma;12112113144149 pulmonary infiltrates with eosinophilia;1112113 or symptomatic exacerbation of allergic conditions122744525870112113144 if prolonged systemic corticosteroid therapy is replaced with oral inhalation corticosteroid therapy.12112113144149 Such symptoms may be observed especially in patients maintained on ≥20 mg of prednisone (or its equivalent) daily and particularly during the later part of the transfer.149

In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by orally inhaled corticosteroids.73

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals.113134135136137138139140141142143144 Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients, particularly in children.113134135136137138139140141142143144

Concomitant Therapy

Use with caution in patients receiving systemic prednisone for any disease.4547 Concomitant use with prednisone in an alternate-day or daily dosing regimen could increase the likelihood of HPA-axis suppression compared with therapeutic dosages of either drug alone.4547

Resume systemic corticosteroids during periods of stress (e.g., infection, trauma, surgery) or a severe asthma exacerbation in patients who were attempting a switch from systemic to orally inhaled corticosteroid therapy.149

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Avoid higher than recommended dosages of the drug, since suppression of HPA function may occur.149 If higher than recommended dosages are used, carefully consider the relative risks of adrenal suppression and potential therapeutic benefits.149 Recommended dosages of orally inhaled drug provide less than normal physiologic amounts of glucocorticoid systemically and do not provide mineralocorticoid activity.149 Orally inhaled drug will not compensate for insufficient endogenous cortisol production caused by previous systemic corticosteroid therapy.149

Respiratory Effects

If bronchospasm occurs, treat immediately with a short-acting bronchodilator, and discontinue treatment with beclomethasone dipropionate and institute alternative therapy.149

Infection

Use with caution, if at all, in patients with clinical tuberculosis or latent M. tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, or parasitic infections; or ocular herpes simplex or untreated, systemic viral infections.12100144149

Sensitivity Reactions

General Precautions

Systemic Corticosteroid Effects

Possible signs and symptoms of Cushing’s syndrome (e.g., hypertension, glucose intolerance, cushingoid features) in patients who are particularly sensitive to corticosteroid effects or when usual dosages of the drug are exceeded.100149

Ocular Effects

Other Effects

Unknown long-term, systemic, and local effects of the drug in humans, particularly developmental or immunologic processes in the mouth, pharynx, trachea, and lung.149

Specific Populations

Pregnancy

Category C.149 (See Systemic Corticosteroid Effects under Cautions.)

Lactation

Distributed into milk.144149 Discontinue nursing or the drug.144149

Pediatric Use

Safety and efficacy not established in children <5 years of age.149 No overall differences in the pattern, severity, or frequency of adverse events in children 5–12 years of age compared with those in adults.149 Monitor periodically children receiving prolonged therapy for possible adverse effects on growth and development.62149

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.149

Use caution due to the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in geriatric patients.149 (See Geriatric Patients under Dosage and Administration.)

QVAR Pharmacokinetics

Absorption

Bioavailability

Absorbed into circulation following oral inhalation, 149 with peak plasma concentrations usually attained at 0.5 hour.149 After oral inhalation, 51–60% of the dose is deposited in the respiratory tract.154

Onset

Relief of respiratory symptoms usually is evident within 24 hours; however, about 1–4 weeks of continuous therapy may be required for optimum effectiveness.149

Distribution

Extent

Glucocorticoids cross the placenta and are distributed into milk.144149a No evidence of tissue storage of parent drug or metabolites.149

Elimination

Metabolism

Metabolized to active metabolites via CYP3A4.149

Elimination Route

Beclomethasone dipropionate and its metabolites eliminated principally in feces and to a lesser extent in the urine (<10%).149

Half-life

2.8 hours.149

Stability

Storage

Oral Inhalation

25°C (may be exposed to 15–30°C).149

Do not puncture aerosol containers, use or store near heat or an open flame, expose to temperatures >49°C, or place into a fire or incinerator for disposal.1112113144149

May reduce the following: number of mediator cells (basophils, leukocytes, and mast cells) at the epithelial level, number of eosinophils, sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity.c